Photodynamic Therapy (PDT) Cholangiocarcinoma Registry (PDTRegistry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01524146
First received: January 27, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States.

The establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.

This multicenter registry has been initiated:

  • To document the impact of PDT on the clinical management of unresectable cholangiocarcinoma.
  • To assess the clinical and technical success rates of PDT for unresectable cholangiocarcinoma.

Condition Intervention
Unresectable Cholangiocarcinoma
Biliary Obstruction
Stent Obstruction
Biliary Stricture
Procedure: Photodynamic Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: To Establish a Multicenter Registry to Evaluate the Impact of Photodynamic Therapy in the Management of Patients With Unresectable Cholangiocarcinoma.

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    Documentation of efficacy: Technical and clinical success rates; and survival duration.

    Effectiveness will be assessed by visual inspection of tissue necrosis in the bile ducts one month post photo dynamic therapy delivery.


  • Concomitant Therapy Effect [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Documentation of concomitant/adjuvant therapy and overall survival duration.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Photodynamic therapy
Subjects who will receive photodynamic therapy for palliation of unresectable Cholangiocarcinoma.
Procedure: Photodynamic Therapy

PDT is a therapeutic approach that specifically targets neoplastic cells.

• PDT involves three components:

  1. Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent.
  2. Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis
  3. Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent.

Technique:

Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy.

Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months.

Other Name: PDT

Detailed Description:

PDT offers a number of practical advantages; it is minimally invasive and has a low complication rate, the procedure can easily be performed by a trained endoscopist, and it is well tolerated. In the trial conducted in Germany, the adverse events of PDT were mild to moderate, predictable, and relatively easy to control. Photosensitivity was the only systemic side effect (seen in only three patients). However, provided that simple guidelines for light exposure are followed, there is minimal risk to the patient, as shown by the low incidence of photosensitivity reactions in this study which all resolved.

A study from the Mayo group included 25 patients with unresectable cholangiocarcinoma who were treated with PDT from 1991 to 2004 showed that the time interval between diagnosis and treatment with PDT is an important predictor of survival following PDT even when adjusted for other potential factors that affect survival such as age, gender, Bismuth stage, presence of tumor mass on imaging and presence of extra biliary spread. Early treatment with PDT may lead to greater preservation of liver function. A recent study by the primary investigator has also recently reported improved survival in patients receiving PDT and stent compared to stent only (16.2 months vs 7.4 months).

Several other European studies have reported the efficacy and safety of PDT for cholangiocarcinoma; however, only a few studies have reported the same in the United States. This is again due to the fact that PDT is not offered as a therapeutic option for unresectable cholangiocarcinoma within US.

However, the establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma.

The involvement of international sites is crucial, as the advanced endoscopists all over the world are offering photodynamic therapy for managing unresectable cholangiocarcinoma. However, because of the non-existence of a registry, and the fact that PDT is not offered in more than a few centers in the US; these cases are often reported with a smaller sample size. The registry hopes to combine all such comparable cases and collect enough relevant data for statistical analyses.

With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects suffering from unresectable Cholangiocarcinoma who have a blocked bile duct or biliary stent.

Criteria

Inclusion Criteria:

  • Any patient who is undergoing PDT for unresectable Cholangiocarcinoma
  • Above 18 years of age

Exclusion Criteria:

  • Any patient who will not undergo PDT for unresectable Cholangiocarcinoma
  • Below 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524146

Contacts
Contact: Michel Kahaleh, M.D. 646-962-4797 mkahaleh@gmail.com
Contact: Monica Gaidhane, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
United States, New York
Weill Medical College of Cornell University Active, not recruiting
New York, New York, United States, 10021
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4000    mik9071@med.cornell.edu   
Contact: Monica R Gaidhane, MD, MPH    646-962-4796    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleg, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michel Kahaleh, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01524146     History of Changes
Other Study ID Numbers: 1111012021
Study First Received: January 27, 2012
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Unresectable Cholangiocarcinoma
Biliary obstruction
Stent obstruction
Biliary stricture
Photodynamic therapy
PDT
Ablation

Additional relevant MeSH terms:
Cholangiocarcinoma
Cholestasis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014